510(k) K905648 ยท CHH Enzymatic Esterase--Oxidase, Cholesterol
CRP LIPID REAGENT TEST PACK
| Applicant | Cirrus Diagnostics, Inc., Chester NJ, US |
| Decision | Substantially Equivalent, Mar 6, 1991 |
| Received | Dec 17, 1990 |
| Type | Traditional |
| FDA record | Open on fda.gov |
Recalls that name K905648
No recall in the FDA data names this 510(k).
Links come from the 510(k) numbers listed on each FDA recall record. We don't infer predicate chains.